Resources
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Introduction of Post-approval Change Management Protocol (PACMP) Mock-up in Japan Preparation
Speaker Presentation Funato Keiko, GlaxoSmithKline K. K., 2020
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Case Study: Industry Experience from PACMP Pilot Program in Japan
Speaker Presentation Kubodera Yoshinori, Chugai Pharmaceutical Co. Ltd., 2020
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ICH Q12 Update and Reflections on the USFDA Established Conditions Pilot Program
Speaker Presentation Welch Joel, CDER, FDA, 2020
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Regulatory Approaches to CMC Development During COVID-19: Challenges and Opportunities
Speaker Presentation Shapiro Marjorie, CDER, FDA, 2020
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Regulatory Challenges: Expediting CMC Development While Ensuring Product Quality
Speaker Presentation Levis Robin, CBER, FDA, 2020
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Communications, Regulatory Flexibilities and Quality Challenges for Biologics in the COVID19 Pandemic: An EMA Perspective
Speaker Presentation Shivji Ragini, European Medicines Agency, 2020
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PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals
Speaker Presentation Honda Futaba, Pharmaceuticals and Medical Devices Agency (PMDA), 2020
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Digital Technology, an Assential Enabler to Meet the Burden of a Pandemic, and Beyond…
Speaker Presentation Lebreton Bénédicte, Genentech, a Member of the Roche Group, 2021
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Pre-License and Pre-Approval Inspections During the COVID-19 Pandemic
Speaker Presentation Peter Qiu Zhihao Peter, CDER, FDA, 2021
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Faster than Fast - Technology Transfer to Meet Demand for a Repurposed Biologic
Speaker Presentation Altenburger Ralf, F. Hoffmann - La Roche Ltd., 2021
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Broadening Narsoplimab Development from Orphan Indication to COVID-19 Treatment: CMC Regulatory Considerations
Speaker Presentation Harris Jonathan, Omeros Corporation, 2021
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Leveraging mRNA Platform Technologies to Enable Pandemic Supply of COVID-19 Vx
Speaker Presentation Combs Rodney, Pfizer Inc., 2021
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Racing to a SARS-CoV-2 Vaccine Using Platformtechnology
Speaker Presentation Hamaker Kent and Krishnan Mahesh, Merck & Co. Inc., 2021
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Use of Platform Analytical Methods to Accelerate Development and Commercialization of Theraputics Designed for Unmet Needs
Speaker Presentation Eris Tamer, Amgen Inc., 2021
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Impact of COVID-19 on Next Generation Sequencing Applications for Adventitious Virus Detection in Vaccine Manufacturing
Speaker Presentation Khan Arifa, CBER, FDA, 2021
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Academic Knowledge & Innovation to Accelerate Successful
Technological Transfer for a COVID-19 Vaccine
Speaker Presentation Bottazzi Maria Elena, Baylor College of Medicine, 2021
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Production of Anti-Coronavirus Disease 2019 Hyperimmune
Globulin from COVID-19 Convalescent Plasma
Speaker Presentation Willis Todd, Grifols, 2021
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Building COVID-19 Testing Capacity from Scratch
Speaker Presentation Storgaard Guldberg Torben, Novo Nordisk A/S, 2021
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Emergency Use Diagnostics in a Pandemic: A Global Perspective
Speaker Presentation Miller Danelle, Roche Diagnostics, 2021
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The Role of Emergency Use Authorization (EUA) in Coivd-19 Diagnostics
Speaker Presentation Karsner Ryan, CDRH, FDA, 2021